NCT04982588

Evolut PRO China Clinical Study

Medtronic CoreValve™ Evolut™ PRO System China Clinical Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).

Detailed description

The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.

Conditions

• Severe, Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve™ Evolut™ PRO System	The system comprised of the following three components: 1. CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV) 2. EnVeo™ PRO Delivery Catheter System (DCS) 3. EnVeo™ PRO Loading System (LS)

Timeline

• Start date: 2021-07-17
• Primary completion: 2023-03-17
• Completion: 2028-05-15
• First posted: 2021-07-29
• Last updated: 2025-12-03
• Results posted: 2024-11-29

Locations

4 sites across 1 country: China